Sensitive drug distribution system and method

ABSTRACT

A drug distribution system and method utilizes a central pharmacy and database to track all prescriptions for a sensitive drug. Information is kept in the database regarding all physicians allowed to prescribe the sensitive drug, and all patients receiving the drug. Abuses are identified by monitoring data in the database for prescription patterns by physicians and prescriptions obtained by patients. Further verification is made that the physician is eligible to prescribe the drug by consulting a separate database, and optionally whether any actions are taken against the physician. Multiple controls beyond those for normal drugs are imposed on the distribution depending on the sensitivity of the drug.

RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 10/322,348, filed Dec. 17, 2002, which application isincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to distribution of drugs, and inparticular to the distribution of sensitive drugs.

BACKGROUND OF THE INVENTION

Sensitive drugs are controlled to minimize ensure that they are notabuse and adverse reactions. Such sensitive drugs are approved forspecific uses by the Food and Drug Administration, and must beprescribed by a licensed physician in order to be purchased byconsumers. Some drugs, such as cocaine and other common street drugs arethe object of abuse and illegal schemes to distribute for profit. Someschemes include Dr. shopping, diversion, and pharmacy thefts. A lockedcabinet or safe is a requirement for distribution of some drugs.

Certain agents, such as gamma hydroxy buterate (GHB) are also abused,yet also are effective for theraputic purposes such as treatment ofdaytime cataplexy in patients with narcolepsy. Some patients however,will obtain prescriptions from multiple doctors, and have them filled atdifferent pharmacies. Still further, an unscrupulous physician mayactually write multiple prescriptions for a patient, or multiplepatients, who use cash to pay for the drugs. These patients will thensell the drug to dealers or others for profit.

There is a need for a distribution system and method that directlyaddresses these abuses. There is a further need for such a system andmethod that provides education and limits the potential for such abuse.

SUMMARY OF THE INVENTION

A drug distribution system and method utilizes a central pharmacy anddatabase to track all prescriptions for a sensitive drug. Information iskept in a central database regarding all physicians allowed to prescribethe sensitive drug, and all patients receiving the drug. Abuses areidentified by monitoring data in the database for prescription patternsby physicians and prescriptions obtained by patients. Furtherverification is made that the physician is eligible to prescribe thedrug by consulting a separate database for a valid DEA license, andoptionally state medical boards to determine whether any corrective orapproved disciplinary actions relating to controlled substances havebeen brought against the physician. Multiple controls beyond those fortraditional drugs are imposed on the distribution depending on thesensitivity of the drug.

Education is provided to both physician and patient. Prior to shippingthe drug for the first time, the patient is contacted to ensure thatproduct and abuse related educational materials have been receivedand/or read. The patient may provide the name of a designee to thecentral pharmacy who is authorized to accept shipment of the drug.Receipt of the initial drug shipment is confirmed by contacting thepatient. Either a phone call or other communication to the patientwithin a set time after delivery may be made to ensure receipt. Further,a courier service's tracking system is used to confirm delivery infurther embodiments. If a shipment is lost, an investigation is launchedto find it.

In one embodiment, the drug may be shipped by the central pharmacy toanother pharmacy for patient pick-up. The second pharmacy's ability toprotect against diversion before shipping the drug must be confirmed.This ability may be checked through NTIS and State Boards of Pharmacy.

Prescription refills are permitted in the number specified in theoriginal prescription. In addition, if a prescription refill isrequested by the patient prior to the anticipated due date, such refillswill be questioned. A lost, stolen, destroyed or spilledprescription/supply is documented and replaced to the extent necessaryto honor the prescription, and will also cause a review or fullinvestigation.

The exclusive central database contains all relevant data related todistribution of the drug and process of distributing it, includingpatient, physician and prescription information. Several queries andreports are run against the database to provide information which mightreveal potential abuse of the sensitive drug, such as early refills.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a computer system for use in implementingthe system and method of the present invention.

FIGS. 2A, 2B and 2C are a flowchart describing a method for sensitivedrug distribution at least partially utilizing a computer system such asthat shown in FIG. 1.

FIG. 3 is a flowchart of a physician success program at least partiallyimplemented on a computer system such as that shown in FIG. 1.

FIGS. 4A and 4B are a flowchart describing a method for handling refillrequests at least partially utilizing a computer system such as thatshown in FIG. 1.

FIG. 5 is a flowchart of a process for requesting special reimbursementwhen a patient is uninsured or underinsured at least partially utilizinga computer system as that shown in FIG. 1.

FIG. 6 is a flowchart of a process for inventory control at leastpartially utilizing a computer system such as that shown in FIG. 1.

FIG. 7 is a block diagram of database fields.

FIG. 8 is a block diagram showing a list of queries against the databasefields.

FIG. 9 is a copy of one example prescription and enrollment form.

FIG. 10 is a copy of one example of a NORD application request form forpatient financial assistance.

FIG. 11 is a copy of one example voucher request for medication for usewith the NORD application request form of FIG. 10.

FIG. 12 is a copy of certificate of medical need.

FIGS. 13A, 13B and 13C are descriptions of sample reports obtained byquerying a central database having fields represented in FIG. 7.

DETAILED DESCRIPTION OF THE INVENTION

In the following description, reference is made to the accompanyingdrawings that form a part hereof, and in which is shown by way ofillustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that other embodiments may be utilized and thatstructural, logical and electrical changes may be made without departingfrom the scope of the present invention. The following description is,therefore, not to be taken in a limited sense, and the scope of thepresent invention is defined by the appended claims.

The functions or algorithms described herein are implemented in softwareor a combination of software and human implemented procedures in oneembodiment. The software comprises computer executable instructionsstored on computer readable media such as memory or other type ofstorage devices. The term “computer readable media” is also used torepresent carrier waves on which the software is transmitted. Further,such functions correspond to modules, which are software, hardware,firmware of any combination thereof. Multiple functions are performed inone or more modules as desired, and the embodiments described are merelyexamples. The software is executed on a digital signal processor, ASIC,microprocessor, or other type of processor operating on a computersystem, such as a personal computer, server or other computer system.

A sensitive drug is one which can be abused, or has addiction propertiesor other properties that render the drug sensitive. One example of sucha drug is sodium oxybate, also known as gamma hydroxy butyrate (GHBC₄H₇NaO₃) which is useful for treatment of cataplexy in patients withnarcolepsy. GHB is marketed under the trademark of Xyrem® (sodiumoxybate oral solution), which trademark can be used interchangeably withGHB herein. Sensitive drugs also include narcotics or other drugs whichrequire controls on their distribution and use to monitor behaviors toprevent abuse and adverse side effects.

In one embodiment, Xyrem® is subject to a restricted distributionprogram. One aspect of the program is to educate physicians and patientsabout the risks and benefits of Xyrem, including support via ongoingcontact with patients and a toll free helpline. Initial prescriptionsare filled only after a prescriber and patient have received and readthe educational materials. Further, patient and prescribing physicianregistries are maintained and monitored to ensure proper distribution.

In a further embodiment, bulk sodium oxybate is manufactured at a singlesite, as is the finished drug product. Following manufacture of the drugproduct, it is stored at a facility compliant with FDA Schedule IIIregulations, where a consignment inventory is maintained. The inventoryis owned by a company, and is managed by a central pharmacy, whichmaintains the consignment inventory. Xyrem® is distributed and dispensedthrough a primary and exclusive central pharmacy, and is not stocked inretail pharmacy outlets. It is distributed by overnight carriers, or byUS mail in one embodiment to potentially invoke mail fraud laws ifattempts of abuse occur.

FIG. 1 is a simplified block diagram of a computer system 100, such as apersonal computer for implementing at least a portion of the methodsdescribed herein. A central processing unit (CPU) 110 executes computerprograms stored on a memory 120. Memory 120 in one embodiment comprisesone or more levels of cache as desired to speed execution of the programand access to data on which the programs operate. The CPU is directlycoupled to memory 120 in one embodiment. Both CPU 110 and memory 120 arecoupled to a bus 130. A storage 140, I/O 150 and communications 160 arealso coupled to the bus 130. Storage 140 is usually a long term storagedevice, such as a disk drive, tape drive, DVD, CD or other type ofstorage device. In one embodiment, storage 140 is used to house adatabase for use with the present invention. I/O 150 compriseskeyboards, sound devices, displays and other mechanisms by which a userinteracts with the computer system 100. Communications 160 comprises anetwork, phone connection, local area network, wide area network orother mechanism for communicating with external devices. Such externaldevices comprise servers, other peer computers and other devices. In oneembodiment, such external device comprises a database server that isused in place of the database on storage 140. Other computer systemarchitectures capable of executing software and interacting with adatabase and users may also be used. Appropriate security measures suchas encryption are used to ensure confidentiality. Further, dataintegrity and backup measures are also used to prevent data loss.

FIGS. 2A, 2B and 2C represent an initial prescription order entryprocess for a sensitive drug, such as Xyrem. At 202, a medical doctor(MD) sends a Rx/enrollment form via mail, fax, email or other means toan intake/reimbursement specialist at 204, who makes a copy of theRX/enrollment form that is stamped “copy”. The original fax is forwardedto a pharmacy team. The enrollment form contains prescriber information,prescription information, checkboxes for the prescriber indicating theyhave read materials, educated the patient, understand the use intreatment, and understand certain safety information, and also containspatient information.

The prescriber information contains standard contact information as wellas license number, DEA number and physician specialty. Patient andprescription information includes name, social security number, date ofbirth, gender, contact information, drug identification, patient'sappropriate dosage, and number of refills allowed, along with a line forthe prescriber's signature. Patient insurance information is alsoprovided.

There are two workflows involved at the pharmacy team, intakereimbursement 206 and pharmacy workflow 208, which may proceed inparallel or serially. The intake work flow 206 starts with an intakereimbursement specialist entering the patient and physician informationinto an application/database referred to as CHIPS, which is used tomaintain a record of a client home infusion program (CHIP) for Xyrem®. Acheck is made to ensure the information is complete at 212. If not, at214, an intake representative attempts to reach the MD or prescriber toobtain the missing information. If the missing information has not beenobtained within a predetermined period of time, such as 24 hours at 216,the Rx/Enrollment form is sent back to the MD with a rejectionexplanation. A note is entered in CHIPS that the application wasrejected.

If the information is complete at 212, the MD is contacted at 220 toverify receipt and accuracy of the patient's Rx. This contact isrecorded in CHIPS. The intake and reimbursement specialist then sends aconsent form and a cover letter to the patient at 224. The insuranceprovider is contacted at 226 to verify coverage and benefits. At 228, adetermination is made regarding coverage for the drug. If it is notavailable, it is determined at 230 whether the patient is willing andable to pay. If not, a process is performed for handling patients whoare uninsured or underinsured. In one embodiment, the process isreferred to as a NORD process.

If the patient is willing and able to pay at 230, the patient isinformed of the cost of the product and is given payment options at 234.At 236, once payment is received, the intake reimbursement specialistsubmits a coverage approval form with the enrollment form to thepharmacy team as notification to process the patient's prescription. Ifcoverage is approved at 228, the intake reimbursement specialist alsosubmits the coveral approval form with the enrollment form to thepharmacy team as notification to process the patient's prescription.Processing of the prescription is described below.

Upon receipt and initial processing of the prescription enrollment formand sending an original to the pharmacy work flow block 208, the patientis shipped a Xyrem® success packet via mail. In one embodiment, theXyrem® success packet contains educational material for a patient thatadvises of the proper use, care and handling of the drug andconsequences of diversion at 268. The medical doctor's credentials arechecked to determine if the physician has a current DEA license toprescribe controlled substances and if he or she has had any actionsrelated to misuse/misprescribing of controlled drugs against him or her,within a predetermined time, such as three months at 270. If they have,a pharmacist holds the prescription until receiving a coverage approvalform from the intake reimbursement specialist at 272.

If the credentials have not been recently checked, the pharmacistverifies the credentials and enters all findings in the database at 274.If the credentials are approved at 276, the physician is indicated asapproved in a physician screen populated by information from thedatabase at 280. The prescription is then held pending coverage approvalat 282.

If any disciplinary actions are identified, as referenced at block 278,management of the pharmacy is notified and either approves processing ofthe prescription with continued monitoring of the physician, orprocessing of the prescription is not performed, and the physician isnoted in the database as unapproved at 284. The enrollment form is thenmailed back to the physician with a cover letter reiterating that theprescription cannot be processed at 288. The patient is also sent aletter at 290 indicating that the prescription cannot be processed andthe patient is instructed to contact their physician.

Actual filling of the approved prescription begins with receipt of thecoverage approval form as indicated at 240. The patient is contacted bythe pharmacy, such as by a technician to complete a technician sectionof a patient counseling checklist. If a pharmacist verifies that theprogram materials were not read at 242, the receipt of the material isconfirmed at 244 and another call is scheduled to counsel the patientbefore the drug is shipped.

If the program materials, were read at 242, the checklist is completedat 246 and the technician transfers the patient to the pharmacist whoreviews the entire checklist and completes remaining pharmacistspecified sections. At 248, the pharmacists indicates in the databasethat the patient counseling and checklist was successfully completed,indicating the date completed.

At 250, the pharmacist schedules the patient's shipment for the nextbusiness day or the next business day that the patient or designee isable to sign for the package. Further, as indicated at 252, the shipmentmust be sent to the patient's home address unless the patient istraveling or has moved. In that event, the pharmacist may determine thatan exception may be made. The patient or the patient's designee who isat least 18 years old, must sign for the package upon delivery.

At 254, the pharmacist enters the prescription order in the database,creating an order number. The pharmacist then verifies at 256 theprescription and attaches a verification label to the hard copyprescription. At 258, a pick ticket is generated for the order and theorder is forwarded to the pharmacy for fulfillment. The shipment isconfirmed in the database at 260, and the order is shipped by USPSExpress Mail. Use of the US mail invokes certain criminal penalties forunauthorized diversion. Optionally, other mail services may be used.Potential changes in the law may also bring criminal penalties intoplay. Following shipment, the patient is called by the central pharmacyto confirm that the prescription was received.

As noted at 266, for the sensitive drug, Xyrem, all inventory is cyclecounted an reconciled with the database system quantities beforeshipments for the day are sent. This provides a very precise control ofthe inventor.

A physician success program materials request process begins at 310 inFIG. 3. At 320, the MD calls to the central pharmacy to request programmaterials. A special phone number is provided. MD demographics, DEAnumber, and data or request are entered into the database at 330. At340, a request is made to ship the materials to the MD via a fulfillmentwebsite, or other mechanism. The request process ends at 350.

A refill request process begins at 302 in FIGS. 4A and 4B. There are twodifferent paths for refills. A first path beginning at 404 involvesgenerating a report from the central database of patients with apredetermined number of days or product remaining. A second pathbeginning at 406 is followed when a patient calls to request an earlyrefill.

In the first path, a copy of the report is provided to an intakereimbursement specialist at 408. No sooner than 8 days before themedication depletion, a pharmacy technician contacts the patient at 410to complete the pre-delivery checklist. At 412, if the patient is notreached, a message is left mentioning the depletion, and a return numberat 414. A note is also entered into the database indicating the date themessage was left at 416.

If the patient is reached at 412, the next shipment is scheduled at 418,the prescription is entered into the database creating an order at 420,the pharmacist verifies the prescription and attaches a verificationlabel at 422 and the shipment is confirmed in the database at 424. Noteat 426 that the inventory is cycle counted and reconciled with thedatabase quantities before the shipments for a day or other time periodare sent. A pick ticket is generated for the order and the order isforwarded for fulfillment at 428, with the first path ending at 430.

The second path, beginning at 406 results in a note code being enteredinto the database on a patient screen indicating an early refill requestat 432. The pharmacist evaluates the patient's compliance with therapyor possible product diversion, misuse or over-use at 436. In oneembodiment, cash payers are also identified. The pharmacist thencontacts the prescribing physician to alert them of the situation andconfirm if the physician approves of the early refill at 438. If thephysician does not approve as indicated at 440, the patient must waituntil the next scheduled refill date to receive additional product asindicated at 442, and the process ends at 444.

If the physician approves at 440, the pharmacist enters a note in thedatabase on a patient screen that the physician approves the request at446. The pharmacist notifies an intake reimbursement specialist tocontact the patient's insurance provider to verify coverage for theearly refill at 448. If the insurance provider will pay as determined at450, the specialist submits the coverage approval form as notificationthat the refill may be processed at 452. At 454, the pharmacy techniciancontacts the patient to schedule shipment of the product for the nextbusiness day, and the process of filling the order is continued at 456by following the process beginning at 240.

If the insurance provider will not pay at 450, it is determined whetherthe patient is willing and/or able to pay at 458. If not, the patientmust wait until the next scheduled refill date to receive additionalproduct at 460. If it was determined at 458 that the patient was willingand able to pay, the patient is informed of the cost of the product andis given payment options at 462. Once payment is received as indicatedat 464, the specialist submits a coverage approval form to the pharmacyteam as notification that the refill request can be processed at 466. At468, the pharmacy technician contacts the patient to schedule shipment.The process of filling the order is continued at 470 by following theprocess beginning at 240.

A process, referred to as a NORD process in one embodiment is used todetermine whether donated, third party funds are available for payingfor prescriptions where neither insurance will, nor the patient can pay.The process begins at 510 upon determining that a patient is uninsuredor underinsured. A reimbursement specialist explains the NORD program tothe patient and faxes an application request form to NORD for thepatient. At 515, the intake reimbursement specialist documents in thedatabase that an application has been received through NORD. At 520,NORD mails an application to the patient within one business day.

A determination is made at 525 by NORD whether the patient is approved.If not, at 530, NORD sends a denial letter to the patient, and it isdocumented in the database at 540 that the patient was denied by NORD.If the patient is approved, NORD sends an acceptance letter to thepatient and faxes a voucher to the central pharmacy (SDS in oneembodiment) to indicate the approval at 545. At 550, an intakereimbursement specialist submits a coverage approval form to thepharmacy team as notification that the patient has been approved forcoverage. The process of filling the order is continued at 555 byfollowing the process beginning at 240.

An inventory control process is illustrated in FIG. 6 beginning at 610.Each week, a responsible person at the central pharmacy, such as thedirector of the pharmacy transfers inventory for the week's shipments toa segregated warehouse location for production inventory. At 620, apurchase order is generated for the inventory transferred to theproduction location and is sent, such as by fax, to a controller, suchas the controller of the company that obtained approval for distributionand use of the sensitive drug. At 630, the controller invoices thecentral pharmacy for the product moved to production. The process endsat 640.

The central database described above is a relational database running onthe system of FIG. 1, or a server based system having a similararchitecture coupled to workstations via a network, as represented bycommunications 160. The database is likely stored in storage 140, andcontains multiple fields of information as indicated at 700 in FIG. 7.The organization and groupings of the fields are shown in one format forconvenience. It is recognized that many different organizations orschemas may be utilized. In one embodiment, the groups of fieldscomprise prescriber fields 710, patient fields 720, prescription fields730 and insurance fields 740. For purposes of illustration, all theentries described with respect to the above processes are included inthe fields. In further embodiments, no such groupings are made, and thedata is organized in a different manner.

Several queries are illustrated at 800 in FIG. 8. There may be manyother queries as required by individual state reporting requirements. Afirst query at 810 is used to identify prescriptions written byphysician. The queries may be written in structured query language,natural query languages or in any other manner compatible with thedatabase. A second query 820 is used to pull information from thedatabase related to prescriptions by patient name. A third query 830 isused to determine prescriptions by frequency, and a n^(th) `query findsprescriptions by dose at 840. Using query languages combined with thedepth of data in the central database allows many other methods ofinvestigating for potential abuse of the drugs. The central databaseensures that all prescriptions, prescribers and patients are tracked andsubject to such investigations. In further embodiments, the centraldatabase may be distributed among multiple computers provided a queryoperates over all data relating to such prescriptions, prescribers andpatients for the drug.

An example of one prescription and enrollment form is shown at 900 inFIG. 9. As previously indicated, several fields are included forprescriber information, prescription information and patientinformation.

FIG. 10 is a copy of one example NORD application request form 1000 usedto request that an application be sent to a patient for financialassistance.

FIG. 11 is a copy of one example application 1100 for financialassistance as requested by form 1000. The form requires both patient andphysician information. Social security number information is alsorequested. The form provides information for approving the financialassistance and for tracking assistance provided.

FIG. 12 is a copy of one example voucher request for medication for usewith the NORD application request form of FIG. 10. In addition topatient and physician information, prescription information anddiagnosis information is also provided.

FIGS. 13A, 13B and 13C are descriptions of sample reports obtained byquerying a central database having fields represented in FIG. 7. Theactivities grouped by sales, regulatory, quality assurance, call center,pharmacy, inventory, reimbursement, patient care and drug information.Each report has an associated frequency or frequencies. The reports areobtained by running queries against the database, with the querieswritten in one of many query languages.

While the invention has been described with respect to a Schedule IIIdrug, it is useful for other sensitive drugs that are DEA or Federallyscheduled drugs in Schedule II-V, as well as still other sensitive drugswhere multiple controls are desired for distribution and use.

1. A method of distributing a sensitive drug, the method comprising:receiving prescription requests from a medical doctor containinginformation identifying the patient, the sensitive drug, and variouscredentials of the doctor; entering the information into a centraldatabase for analysis of potential abuse situations; checking thecredentials of the doctor; confirming with the patient that educationalmaterial has been read prior to shipping the sensitive drug; confirmingreceipt of the sensitive drug; and generating periodic reports via thecentral database to evaluate potential abuse patterns.
 2. The method ofclaim 1 wherein receipt of the sensitive drug is confirmed by telephonecall from the central pharmacy to the patient.
 3. The method of claim 1and further comprising launching an investigation of lost shipments. 4.The method of claim 1 and further comprising recording the confirmationwith the patient that the educational material has been read in thecentral database.
 5. The method of claim 1 and further comprisingverifying the patient's home address.
 6. The method of claim 1 andfurther comprising recording a designee identified by the patient toreceive the sensitive drug.
 7. The method of claim 1 and furthercomprising establishing a delivery date.
 8. The method of claim 1wherein prescription refills requested prior to an anticipated date arequestioned by the pharmacist.
 9. The method of claim 1 and furthercomprising shipping comprehensive printed materials to the physician ifthe physician is a first time prescriber of the sensitive drug.
 10. Themethod of claim 1 wherein the credentials of the doctor comprise DEA(Drug Enforcement Agency) and state license numbers.
 11. A method ofmonitoring potential abuse of a sensitive drug by use of an exclusivecentral database, the method comprising: generating queries ofprescription information from a database containing selected informationfor all prescriptions of the sensitive drug, wherein the queriescomprise prescriptions by physician specialty, prescriptions by patientname, prescriptions by frequency and prescriptions by dose.
 12. Themethod of claim 11 and further comprising running multiple predeterminedreports based on data in the exclusive central database.
 13. The methodof claim 12 wherein such reports are selected from groups of reportsconsisting of sales, regulatory, quality assurance, pharmacy, inventory,reimbursement, patient care, and drug information.
 14. The method ofclaim 13 wherein sales reports are selected from the group consisting ofprescriptions by zip code, prescriptions by physician by zip code andtotal dollars by zipcode.
 15. The method of claim 13 wherein regulatoryreports are selected from the group consisting of number of physicianregistries, number of denied physician registries and reasons, number ofcompleted patient registries, number of problem identification, numberof cycle counts performed.
 16. The method of claim 13 wherein inventoryreports are selected from the group consisting of number of returnedproducts and reasons, number of outdated bottles of product, inventorycounts of consignment and production inventory, number of unitsreceived, and lots received.
 17. The method of claim 13 wherein patientcare reports are selected from the group consisting of number of adverseevents, number of dosing problems and type, number of noncomplianceepisodes and reason, number of patients counseled and reason, number ofdiscontinued and reason, number of patients referred to physician andreason, number of active patients, number of new patents, number ofrestart patients, and number of discontinued patients and reason. 18.The method of claim 13 wherein selected reports are run weekly, monthlyor quarterly.
 19. A method of obtaining FDA (Food and DrugAdministration) approval for a sensitive drug, the method comprising:determining current and anticipated patterns of potential abuse of thesensitive drug; selecting multiple controls for distribution by anexclusive central pharmacy maintaining a central database, the controlsselected from the group consisting of communicating prescriptions from aphysician to the central pharmacy, identifying the physicians name,license and DEA (Drug Enforcement Agency) registration information,verifying the prescription; obtaining patient information, verifying thephysician is eligible to prescribe the sensitive drug by consulting theNational Technical Information Services to determine whether thephysician has an active DEA number and check on whether any actions arepending against the physician, provide comprehensive printed materialsto the physician, contacting the patient's insurance company if any,verifying patient registry information, providing comprehensiveeducation information to the patient, verifying the patient has reviewedthe educational materials, verifying the home address of the patient,shipping via US postal service or similar shipping service, receivingthe name of an at least 18 year old designee to receive the drug,confirming receipt of an initial shipment of the drug to the patient,returning the drug to the pharmacy after two attempts to deliver,launching an investigation when a shipment is lost, shipping to anotherpharmacy for delivery, requiring manufacture at a single location,releasing inventory in a controlled manner to the central pharmacy,questioning early refills, flagging repeat instances of lost, stolen,destroyed or spilled prescriptions, limiting the prescription to a onemonth supply, requiring rewriting of the prescription periodically,making the database available to the DEA for checking for abuse patternsin the data, cash payments, inappropriate questions; and negotiatingwith the FDA by adding further controls from the group until approval isobtained.
 20. The method of claim 19 wherein initially selected controlscomprise communicating prescriptions from a physician to the centralpharmacy, identifying the physicians name, license and DEA registrationinformation, verifying the prescription; obtaining patient information,verifying the physician is eligible to prescribe the sensitive drug byconsulting the National Technical Information Services to determinewhether the physician has an active DEA number and check on whether anyactions are pending against the physician, verifying patient registryinformation, providing comprehensive education information to thepatient, verifying the patient has reviewed the educational materials,verifying the home address of the patient, shipping via US postalservice, confirming receipt of an initial shipment of the drug to thepatient releasing inventory in a controlled manner to the centralpharmacy, flagging repeat instances of lost, stolen, destroyed orspilled prescriptions, and making the database available to the DEA forchecking for abuse patterns in the data
 21. The method of claim 19wherein the sensitive drug is a scheduled drug in Schedule II-V.
 22. Amethod of distributing a sensitive drug, the method comprising:determining current and anticipated patterns of potential abuse of thesensitive drug; selecting multiple controls for distribution of thesensitive drug; and adding additional controls to provide sufficientreassurance to a governmental regulatory body that the sensitive drugdistribution can be adequately controlled in order to obtain marketingapproval by the governmental regulatory body.
 23. The method of claim 22wherein the system allows marketing of a drug product pursuant to FDAsubpart 4 regulation embodied in Title 21, CFR Part
 314. 24. The methodof claim 22 wherein distribution of the sensitive drug is controlled bya central distribution center sufficient to allow the DEA (DrugEnforcement Agency) to approve the central distribution center.
 25. Themethod of claim 22 wherein the governmental regulatory body comprises astate regulatory agency that approves distribution of the sensitive drugin a state.
 26. A method comprising: controlling the distribution of asensitive drug via an exclusive central pharmacy that maintains acentral database that tracks all prescriptions of said sensitive drugand analyzes for potential adverse reaction situations; determiningcurrent and anticipated patterns of potential adverse reactions to saidsensitive drug from periodic patient care reports generated by thecentral database; and selecting multiple controls for distribution bysaid exclusive central pharmacy; whereby an adverse reaction to thesensitive drug is controlled by the method.
 27. The method of claim 26wherein patient care reports are selected from the group consisting ofnumber and type of adverse events; number of adverse events sent to theOMI; number and type of dosing problems; number of episodes ofnoncompliance and reasons for noncompliance; number of patientscounseled and reason for counseling; number of patients discontinued andreason for discontinuance; number of patients referred to a physicianand reason for referral; number of active patients; number of newpatients; and number of restart patients.
 28. The method of claim 27wherein reports are run weekly, monthly, or quarterly
 29. The method ofclaim 26 wherein the central database contains patient, physician, andprescription information.
 30. The method of claim 26 wherein thecontrols for distribution are selected from the group consisting ofcommunicating prescriptions from a physician to the central pharmacy;identifying the physicians name, license, and DEA (Drug EnforcementAgency) registration information; verifying the prescription; obtainingpatient information; verifying the physician is eligible to prescribethe sensitive drug by consulting the National Technical InformationServices to determine whether the physician has an active DEA number andto check on whether any actions are pending against the physician;providing comprehensive printed materials to the physician; contactingthe patient's insurance company if any; verifying patient registryinformation; providing comprehensive education information to thepatient; verifying the patient has reviewed the educational materials;shipping to another pharmacy for delivery; and requiring rewriting ofthe prescription periodically.
 31. The method of claim 26 whereindistribution of the sensitive drug is controlled by the central pharmacyin a manner sufficient to allow the DEA (Drug Enforcement Agency) toapprove the central pharmacy.
 32. The method of claim 26 wherein thesensitive drug is a scheduled drug in Schedule II-V.
 33. A therapeuticmethod for treating a patient in need of treatment with a sensitive drugthat is effective for therapeutic purposes, but is also a drug that haspotential to be abused comprising: controlling the distribution of saidsensitive drug via an exclusive central pharmacy that maintains acentral database that tracks all prescriptions of said sensitive drugand analyzes for potential abuse situations by determining current andanticipated patterns of potential prescription abuse of said sensitivedrug from periodic reports generated by the central database based onprescription request data from a medical doctor, wherein said requestdata contain information identifying the patient, the drug prescribed,and credentials of the doctor; and selecting multiple controls fordistribution by said exclusive central pharmacy, the controls selectedfrom the group consisting of communicating prescriptions from aphysician to the central pharmacy; identifying the physicians name,license, and DEA (Drug Enforcement Agency) registration information;verifying the prescription; obtaining patient information; verifying thephysician is eligible to prescribe the sensitive drug by consulting theNational Technical Information Services to determine whether thephysician has an active DEA number and to check on whether any actionsare pending against the physician; providing comprehensive printedmaterials to the physician; contacting the patient's insurance companyif any; verifying patient registry information; providing comprehensiveeducation information to the patient; verifying the patient has reviewedthe educational materials; verifying the home address of the patient;shipping via US postal service or similar shipping service; receivingthe name of an at least 18 year old designee to receive the drug;confirming receipt of an initial shipment of the drug to the patient;returning the drug to the pharmacy after two attempts to deliver;launching an investigation when a shipment is lost; shipping to anotherpharmacy for delivery; requiring manufacture at a single location;releasing inventory in a controlled manner to the central pharmacy;questioning early refills; flagging repeat instances of lost, stolen,destroyed, or spilled prescriptions; limiting the prescription to a onemonth supply; requiring rewriting of the prescription periodically; andmaking the database available to the DEA for checking for abuse patternsin the data, for cash payments, and for inappropriate questions; fillingby the central pharmacy of a prescription for the sensitive drug thathas been subjected to said multiple controls and has been approved forshipment to the patient; shipping the sensitive drug by the centralpharmacy to the patient in order to begin treatment therewith; andtreating the patient with the drug.
 34. The method of claim 33 whereinthe controls for distribution are communicating prescriptions from aphysician to the central pharmacy; identifying the physicians name,license, and DEA (Drug Enforcement Agency) registration information;verifying the prescription; obtaining patient information; verifyingpatient registry information; providing comprehensive educationinformation to the patient; verifying the patient has reviewed theeducational materials; or requiring rewriting of the prescriptionperiodically.
 35. A therapeutic method for treating a narcolepticpatient in need of treatment with gamma hydroxy butyrate (GHB) fordaytime cataplexy comprising: controlling the distribution of GHB via anexclusive central pharmacy that maintains a central database that tracksall prescriptions of GHB and analyzes for potential abuse situations bydetermining current and anticipated patterns of potential prescriptionabuse of GHB from periodic reports generated by the central databasebased on prescription request data from a medical doctor, wherein saidrequest data contain information identifying the patient, GHB as thedrug prescribed, and credentials of the doctor; and selecting multiplecontrols for distribution by said exclusive central pharmacy, thecontrols selected from the group consisting of communicatingprescriptions from a physician to the central pharmacy; identifying thephysicians name, license, and DEA (Drug Enforcement Agency) registrationinformation; verifying the prescription; obtaining patient information;verifying the physician is eligible to prescribe the sensitive drug byconsulting the National Technical Information Services to determinewhether the physician has an active DEA number and to check on whetherany actions are pending against the physician; providing comprehensiveprinted materials to the physician; contacting the patient's insurancecompany if any; verifying patient registry information; providingcomprehensive education information to the patient; verifying thepatient has reviewed the educational materials; verifying the homeaddress of the patient; shipping via US postal service or similarshipping service; receiving the name of an at least 18 year old designeeto receive the drug; confirming receipt of an initial shipment of thedrug to the patient; returning the drug to the pharmacy after twoattempts to deliver; launching an investigation when a shipment is lost;shipping to another pharmacy for delivery; requiring manufacture at asingle location; releasing inventory in a controlled manner to thecentral pharmacy; questioning early refills; flagging repeat instancesof lost, stolen, destroyed, or spilled prescriptions; limiting theprescription to a one month supply; requiring rewriting of theprescription periodically; and making the database available to the DEAfor checking for abuse patterns in the data, for cash payments, and forinappropriate questions; filling by the central pharmacy of aprescription for GHB that has been subjected to said multiple controlsand has been approved for shipment to the patient; shipping the GHB bythe central pharmacy to the patient in order to begin treatmenttherewith; and treating the patient with GHB.
 36. The method of claim 35wherein the controls for distribution are communicating prescriptionsfrom a physician to the central pharmacy; identifying the physiciansname, license, and DEA (Drug Enforcement Agency) registrationinformation; verifying the prescription; obtaining patient information;verifying patient registry information; providing comprehensiveeducation information to the patient; verifying the patient has reviewedthe educational materials; or requiring rewriting of the prescriptionperiodically.